Nexium is a popular heart burn drug that belongs to a class of medications called proton pump inhibitors (PPIs). While very effective in treating GERD (gastroesophageal reflux disease or acid reflux disease), Nexium may be associated with a number of serious side effects, including bone fractures and kidney problems.

What is Nexium?

Nexium – the “Little Purple Pill” – was launched as a prescription medication by AstraZeneca in 2001. Nexium and other PPIs reduce the production of acid by blocking an enzyme in the wall of the stomach that produces acid. The prescription medication is indicated for:

  • Treatment of GERD
  • Treatment of conditions involving excessive stomach acid such as Zollinger-Ellison syndrome
  • Treatment of esophagitis
  • Prevention of gastric ulcers

Following its launch, Nexium quickly became a popular prescription medication, netting AstraZeneca more than $14 billion by 2005. In 2012, Pfizer, Inc. acquired exclusive global rights from AstraZeneca to market non-prescription Nexium. In 2004, the FDA approved over-the-counter Nexium 24HR.

Nexium Side Effects

Nexium users should check with their doctor if they experience any of the following:

  • Blistering, peeling, or loosening of the skin
  • Bloating
  • Chills
  • Constipation
  • Cough
  • Dark urine
  • Swallowing difficulty
  • Dizziness
  • Drowsiness
  • Rapid heartbeat
  • Fever
  • Indigestion
  • Joint or muscle pain
  • Loss of appetite
  • Mood or mental changes
  • Muscle spasms or twitching
  • Nausea
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Red skin lesions, often with a purple center
  • Red, irritated eyes
  • Seizures
  • Skin rash, hives, itching
  • Sore throat
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Tightness in the chest
  • Trembling
  • Unusual tiredness or weakness
  • Vomiting
  • Yellow eyes or skin

Study Finds Nexium May Damage Blood Vessels

New research indicates that long-term exposure to Nexium and other proton pump inhibitors may cause the blood vessels to age more rapidly. According to a study published in Circulation Research in May 2016, this could explain the possible association between the drugs and certain serious complications, including heart attacks and kidney failure. Read More

PPIs and Kidney Disease

In 2016, a study published in JAMA: Internal Medicine reported that patients treated with PPIs might be more likely to develop Chronic Kidney Disease (CKD). The study drew data from 10,500 patients who used PPIs between 1996 and 2015, and found that those who used the drugs twice a day were 46% more likely to develop CKD. Those who used a PPI once per day had a 15% higher risk. Read More

A second study published that same year in the Journal of the American Society of Nephrology suggested that patients who use Nexium and other proton pump inhibitors may be more likely to develop kidney failure or chronic kidney disease compared to those who took another class of heartburn medications. Overall, the results suggested that patients taking the medications are 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease. Riske increased  with higher doses and longer duration of use. Read More

Nexium and Heart Attacks

In June 2015, a study published in PLOS One linked the use of PPIs to an increased risk of heart attack. The study looked at medical records from 2.9 million patients who were using drugs, and suggested that patients who take the medications had a 16 to 21% increased risk of having a heart attack.

Study Finds Nexium May Raise Dementia Risk

Seniors who take Nexium and other proton pump inhibitors may face an increased risk of dementia, according to a recently-published study. The research, which appeared  JAMA Neurology in April 2016, suggested that regular proton pump inhibitor use was associated with a 44% increased risk of dementia compared with those not receiving the medications. Read More

Study Questions Nexium Dosage for Women

A study published in May 2016 suggested that women who used Nexium and similar heartburn drugs would do just as well on lower doses. Published in the  Journal of Clinical Gastroenterology, the study involved around 100 patients, roughly half male and half female. All had been diagnosed with erosive esophagitis, and all had been undergoing long-term therapy with proton pump inhibitor. Half were treated with a reduced dose for an 8 week period. According to the authors of the report, women were three times more likely to tolerate the lower dosage compared to men. Read More

FDA Nexium Warnings

  • Bone Fractures: In 2010, the FDA warned that patients who use Nexium and other prescription proton pump inhibitors may be more likely to experience fractures of the hip, spine and wrists. The risk appeared to be greatest among individuals over age 50, and among patients receiving the highest doses for a year or more. The risk of bone fractures did not extend to the use of over-the-counter PPIs.
  • Low Serum Magnesium Levels: In March 2011, an FDA Drug Safety Communication warned that long-term use of proton pump inhibitors had been associated with hypomagnesaemia (low serum magnesium levels). This condition can lead to muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures).

FDA Responds to Public Citizen Petition

In 2011, the consumer advocacy group, Public Citizen, filed a petition with the FDA asking the agency to add new safety information to the labels for all prescription PPIs, including Nexium. Among other things, the group wanted information regarding pneumonia and bone fractures highlighted in a Black Box, the FDA’s most serious safety warning.

In 2014, the FDA granted part of Public Citizen’s petition, but stopped short of including the Black Box Warning sought by the group. Safety information added to PPI labesl included:

  • Clostridium difficile-associated diarrhea
  • Vitamin B12 deficiency
  • Acute interstitial nephritis (Kidney inflammation)
  • Recommended treatment length for gastroesophageal reflux disease (GERD)
  • Drug interactions with methotrexate (a cancer drug that can remain in the body and become toxic) and mycophenolate mofetil
  • Drug interactions with Plavix (clopidogrel), a blood-thinner that may be less effective in patients on heartburn drugs

Nexium Litigation

In December 2010, the U.S. Judicial Panel on Multidistrict Litigation centralized all Nexium bone fracture lawsuits in the U.S. District Court, Central District of California.

  1. FDA (2012) “Nexium: Highlights of Prescribing Information”
  2. Pfizer (2014) “Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium® 24HR”
  3. JAMA: Internal Medicine (2016) “Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease”
  4. PLOS One (2015) “Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population”
  5. FDA (2010) “FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors”
  6. FDA (2011) FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)


Last Modified: July 27, 2016

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